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    NDC 65219-0131-20 Cyclophosphamide 1 g/50mL Details

    Cyclophosphamide 1 g/50mL

    Cyclophosphamide is a INTRAVENOUS; ORAL INJECTION, POWDER, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is CYCLOPHOSPHAMIDE.

    Product Information

    NDC 65219-0131
    Product ID 65219-131_b11946ea-c5bc-4cc0-9f2c-2198dbc62ddd
    Associated GPIs
    GCN Sequence Number 008765
    GCN Sequence Number Description cyclophosphamide VIAL 1 G INTRAVEN
    HIC3 V1A
    HIC3 Description ANTINEOPLASTIC - ALKYLATING AGENTS
    GCN 38352
    HICL Sequence Number 003893
    HICL Sequence Number Description CYCLOPHOSPHAMIDE
    Brand/Generic Generic
    Proprietary Name Cyclophosphamide
    Proprietary Name Suffix n/a
    Non-Proprietary Name cyclophosphamide
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, FOR SOLUTION
    Route INTRAVENOUS; ORAL
    Active Ingredient Strength 1
    Active Ingredient Units g/50mL
    Substance Name CYCLOPHOSPHAMIDE
    Labeler Name Fresenius Kabi USA, LLC
    Pharmaceutical Class Alkylating Activity [MoA], Alkylating Drug [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA204555
    Listing Certified Through 2024-12-31

    Package

    NDC 65219-0131-20 (65219013120)

    NDC Package Code 65219-131-20
    Billing NDC 65219013120
    Package 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-131-20) / 50 mL in 1 VIAL, SINGLE-DOSE
    Marketing Start Date 2023-11-17
    NDC Exclude Flag N
    Pricing Information N/A